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Last Updated: June 21, 2024

Hydrocortisone - Generic Drug Details


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What are the generic drug sources for hydrocortisone and what is the scope of freedom to operate?

Hydrocortisone is the generic ingredient in seventy-six branded drugs marketed by Allergan Herbert, Crown Labs, Salix Pharms, Bayer Pharms, Monarch Pharms, Valeant Pharm Intl, Westwood Squibb, Pharm Assoc, C And M Pharma, Actavis Mid Atlantic, Alpharma Us Pharms, Altana, Ambix, Chartwell Molecular, Encube, Everylife, Fougera Pharms Inc, G And W Labs, Ingram Pharm, Ivax Pharms, Naska, Padagis Us, Perrigo New York, Pharmaderm, Pharmafair, Rising, Stiefel, Syosset, Taro, Teva, Topiderm, Usl Pharma, Whiteworth Town Plsn, Valeant Intl, Bausch, Chartwell, Ani Pharms, Teva Pharms, Healthpoint, Eton, Pharmacia And Upjohn, Baker Norton, Legacy Pharma, Solvay, Beta Dermac, Bluline, Heran, Fougera Pharms, Mericon, Dow Pharm, Pfizer Global, Cmp Pharma Inc, Dermik Labs, Torch, X Gen Pharms, Paddock Llc, Mission Pharma, Pfizer, Aurobindo Pharma Ltd, Barr, Elkins Sinn, Ferrante, Hikma Intl Pharms, Impax Labs, Impax Labs Inc, Inwood Labs, Nexgen Pharma Inc, Panray, Parke Davis, Purepac Pharm, Roxane, Sandoz, Strides Pharma, Watson Labs, Merck, Pfipharmecs, Mylan Speciality Lp, Able, Cenci, Imperium, Sebela Ireland Ltd, Bel Mar, Epic Pharma Llc, Fera Pharms, Colgate, Genus, Ferndale Labs, Glenmark Pharms Ltd, Taro Pharm Inds, Yamanouchi, Precision Dermat, Lupin Ltd, The J Molner, Abbott, Hospira, Abraxis Pharm, Baxter Hlthcare, Intl Medication, Cosette, Encube Ethicals, Padagis Israel, Sun Pharm Inds Inc, Amring Pharms, Bausch And Lomb, Casper Pharma Llc, Schering, Actavis Labs Fl Inc, Forest Labs, Lederle, and Bioglan, and is included in two hundred and fifty-eight NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Hydrocortisone has fifty-six patent family members in twenty-five countries.

There are sixty-seven drug master file entries for hydrocortisone. Thirty-eight suppliers are listed for this compound.

Drug Prices for hydrocortisone

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Drug Sales Revenue Trends for hydrocortisone

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Recent Clinical Trials for hydrocortisone

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of North Carolina, Chapel HillPhase 4
Institute of Liver and Biliary Sciences, IndiaN/A
The Gothenburg Society of MedicineN/A

See all hydrocortisone clinical trials

Pharmacology for hydrocortisone
Medical Subject Heading (MeSH) Categories for hydrocortisone

US Patents and Regulatory Information for hydrocortisone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira A-HYDROCORT hydrocortisone sodium succinate INJECTABLE;INJECTION 085931-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pharmacia And Upjohn NEO-CORTEF hydrocortisone acetate; neomycin sulfate OINTMENT;TOPICAL 060751-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Altana HYDROCORTISONE hydrocortisone CREAM;TOPICAL 080848-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for hydrocortisone

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Takeda Pharmaceuticals International AG Ireland Branch Plenadren hydrocortisone EMEA/H/C/002185
Treatment of adrenal insufficiency in adults.
Authorised no no no 2011-11-03
Diurnal Europe B.V. Alkindi hydrocortisone EMEA/H/C/004416
Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).
Authorised no no no 2018-02-09
Diurnal Europe B.V. Efmody hydrocortisone EMEA/H/C/005105
Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.
Authorised no no no 2021-05-27
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for hydrocortisone

Country Patent Number Title Estimated Expiration
Israel 242275 הרכב המכיל הידרוקורטיזון (Composition comprising hydrocortisone) ⤷  Sign Up
Cyprus 1123284 ⤷  Sign Up
Brazil 112014011745 composição farmacêutica, e, processo para a fabricação de uma composição farmacêutica de hidrocortisona ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for hydrocortisone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0809498 10C0038 France ⤷  Sign Up PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
0809498 SPC/GB10/012 United Kingdom ⤷  Sign Up PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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